Contact

Phone    +49(0)241 94314-0
Fax       +49(0)241 94314-19
eMail  office(at)osthus(dot)com



News

24.25.05 GBX Summit- London  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Compliance

Plan – Approve – Perform – Validate – Document.

In regulated industries such as the pharmaceutical industry, the provision and implementation of software-based solutions is governed by the general regulations specified by the European and the U.S. authorities. These guidelines are, among others, GAMP4, GMP – Eudralex vol. 4, GCP– Eudralex vol. 10, the German Arzneimittelgesetz AMG (ordinance on the production of pharmaceuticals and active pharmaceutical ingredients) & AMWHV (ordinance on the production of pharmaceuticals and active pharmaceutical ingredients), the GLP (guidelines for good laboratory practice) – 2000/9/EG, PV – volume 9A, and the U.S. regulation FDA 21 CFR part 11.

Complying with these general regulations is an integral part of our projects, solutions and services.

OSTHUS has already passed a number of supplier audits.

On demand, we are capable of meeting the special documentation requirements made on software projects requiring validation. This includes, in particular, running validation tests before production roll-out as well as the change management processes during business operations.

Links to a number of websites listing regulatory requirements:

► GLP
Richtlinien über die Gute Laborpraxis (GLP) (guidelines for good laboratory practice)

► ISO 9001:2000
Quality management systems - Requirements

► GAMP4
The Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture

► GLP und andere QS Systeme
“GLP und andere QS Systeme” (Handbuch zur Überwachung der Einhaltung der Grundsätze der guten Laborpraxis für Inspektorinnen und Inspektoren) (“GLP and other QS systems“ (a supervisor’s manual for monitoring compliance with the principles of good laboratory practice))

► GMP
Since 9 November 2006 an official German version of the EG GMP guidelines has been available. The German version, which is indispensable for an interpretation of what is stipulated in the Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV, ordinance on the production of pharmaceuticals and active pharmaceutical ingredients), has thus become binding in Germany.

► EudraLex
Volume 4 Good manufacturing practice (GMP) Guidelines

► AMWHV
Arzneimittel- und Wirkstoffherstellungsverordnung (ordinance on the production of pharmaceuticals and active pharmaceutical ingredients)

► AMG
Gesetz über den Verkehr mit Arzneimitteln (German law on handling pharmaceuticals)